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QuantumCam Gamma Camera System

by Ddd-Diagnostic A/S

QuantumCam Gamma Camera System (9SYS2070) is a Class II device made by Ddd-Diagnostic A/S, cleared under FDA 510(k) K140206 on 8 May 2014, registered in EUDAMED and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 05711665003002), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K140206

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05711665003002 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK140206 Date8 May 2014DecidedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K140206 decided 8 May 2014 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 05711665003002 listed 15 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140206
  2. Listed FDA GUDID 05711665003002

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
QuantumCam
Generic name
Stationary gamma camera system
Model / Ref / Catalog
QuantumCam Gamma Camera System, 9SYS2070
Primary DI / UDI-DI
05711665003002
510(k) Number
FDA product code
KPS
GMDN term
Stationary gamma camera system
Device class
Class II
Regulation number
892.1200
GUDID distribution status
In Commercial Distribution
Size
Weight — 2144 Kilogram
Height — 225 Centimeter
Depth — 197 Centimeter
Width — 291 Centimeter

Related devices

Category: Stationary gamma camera system

Cleared under the same submission (K140206)

Similar devices in this category

Other devices filed under Stationary gamma camera system.

Other devices from Ddd-Diagnostic A/S

See all devices from Ddd-Diagnostic A/S →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)